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Environmental Decision Memo for Food Contact Notification No. 000023

Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or
the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.

Date: March 15, 2000

From: Environmental Chemist, Environmental Review Team (ERT)
Division of Product Manufacture and Use (HFS-246)

Subject: Premarket Notification FCN No. 000023 for Use of C.I. Pigment Red No. 277 as a Colorant for Polymers

Notifier: Engelhard Corporation
Louisville, KY 40212

To: Division of Petition Control (HFS-215)
Attention: Julius Smith
Through: Team Leader, ERT

Attached is the Environmental Assessment (EA) and Finding of No Significant Impact (FONSI) that we have prepared for the above cited PMN submission. When this PMN becomes effective, the EA/FONSI should be made available to the public. Please let us know if there is any change in the identity or use of the food contact substance that would be inconsistent with the identity and use described in the FONSI.

John L. Dennison

Environmental Assessment for FCN No. 000023

1. Description of the Proposed Action

The proposed action is to provide for a solid solution of 1-naphthalenesulfonic acid, 2-[(2-hydroxy-6-sulfo-1-naphthalenyl)azo]-, strontium salt (1:1) (CAS Registry No. 250639-61-1) and 2-naphthalenesulfonic acid, 5-[(4-chloro-5-ethyl-2-sulfophenyl)azo]-6-hydroxy-, strontium salt (1:1) (CAS Registry No. 197566-87-3) (C.I. Pigment Red 277) for use as a colorant for all types of polymers intended for food contact. This action was originally requested by the Engelhard Corporation in Food Additive Petition (FAP) 9B4667, which was filed on May 26, 1999. The notice of filing, published in the Federal Register on July 6, 1999 [64 FR 36361], contained the Agency's decision that approval of the petition would qualify for a categorical exclusion under 21 CFR 25.32(i). This exclusion is for actions for substances present in finished food-packaging material at not greater than 5 percent-by-weight and that are expected to remain with finished food-packaging material through use by consumers or when the substance is a component of a coating of a finished food-packaging material.

The Food and Drug Administration Modernization Act (FDAMA) of 1997 (Pub. L. 105-115) amended section 409 of the Federal Food, Drug, and Cosmetic Act (FFDCA) to establish a premarket notification (PMN) process as the primary method for authorizing new uses of food additives that are food contact substances (FCSs). Section 409(h)(6) of the act defines an FCS as any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food. Under the PMN process, a notification becomes effective 120 days after the date of receipt by FDA, unless FDA determines that, based on the data and information before the agency, the use of the substance is not safe and FDA objects to such notification within the 120-day period. If FDA does not object within 120 days to the use of a food contact substance that is the subject of a PMN, the substance may be legally marketed for the notified use.

In a letter dated October 26, 1999, the Agency told petitioners and requestors who had pending food additive petitions or threshold of regulation exemption requests involving the use of an FCS that the petitioned or requested action might be eligible for notification under section 409(h) of the FFDCA. The petitioners were told that they could consider withdrawing such petition or request and resubmitting it as a PMN. In a letter dated December 9, 1999, Englehard Corporation requested that FAP 9B4667 be converted to a PMN.

The types of substances and the uses of such substances under the categorical exclusion in 21 CFR 25.32(i) are the same whether a sponsor submits a food additive petition, a request for exemption from regulation as a food additive under 21 CFR §170.39, or a PMN. However, a categorical exclusion for allowing a PMN to become effective is not currently one of the enumerated types of actions listed in §25.32(i). Therefore, we have prepared this Environmental Assessment(EA) for the subject notification.

2. Environmental Consequences of the Proposed Action

This action involves an FCS that is a minor component of finished food-packaging materials (<5% by weight of the finished packaging material) that remains with the packaging through use by consumers. We have found that the very small quantities of substances that could potentially enter the environment from this type of use are highly unlikely to have a significant effect on the environment (61 FR 19476 at 19481-82, May 1, 1996). The basis for the Agency's decision to establish the categorical exclusion in §25.32(i) for food additive petitions is the same basis that would be applicable to PMNs. Therefore, the Agency's experience with the food additive petitions that it reviewed to support a categorical exclusion for such actions is relevant to PMNs.

The principal routes of environmental introduction of the types of substances included under §25.32(i), whether reviewed in a food additive petition or PMN, result from their disposal in municipal solid waste combustors or landfills. These routes of disposal are governed by the regulations of the Environmental Protection Agency (EPA) in 40 CFR part 60 (combustors) and part 258 (landfills). Based on the low levels of use of these substances in packaging material, the introduction of combustion products or introductions at landfill sites are not environmentally significant. The notifier states that the proposed maximum level of the additive in the food-packaging material will be not greater than 5 percent by weight and that it is expected to remain with the finished food-packaging material through use by consumers. Because of the nature of this type of action, we do not expect that any limited increase in environmental introductions resulting from this proposed action will threaten a violation of EPA's regulations governing combustors and landfills or have any other adverse environmental effects. In addition, one of the primary objectives for the development of this pigment was to reduce environmental risks posed by the heavy metals contained in lead chromate and cadmium pigments. The subject pigment was developed as an alternative to these colorants, and EPA recognized Engelhard for their developmental efforts by an award for their environmental stewardship. A copy of the recognition award is in FAP 9B4667.

In the claim of categorical exclusion in FAP 9B4667, the petitioner stated that the FCS will not present an extraordinary circumstance that would require the submission of an Environmental Assessment. We do not believe that the conversion of this petition to a PMN would alter the fact that no extraordinary circumstances are likely to occur as a result of this action.

3. Alternatives to the Proposed Action

Alternatives to the proposed action need not be considered, because no potential adverse environmental effects have been identified.

4. List of Preparers

John L. Dennison
Environmental Chemist
Environmental Review Team
Division of Product Manufacture and Use
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Finding of No Significant Impact

A Premarket Notification (FCN No. 000023), submitted by Engelhard Corporation, to provide for the safe use of a solid solution of 1-naphthalenesulfonic acid, 2-[(2-hydroxy-6-sulfo-1-naph-thalenyl)azo]-, strontium salt (1:1) and 2-naphthalenesulfonic acid, 5-[(4-chloro-5-ethyl-2-sulfophenyl)azo]-6-hydroxy-, strontium salt (1:1) (C.I. Pigment Red 277) as a colorant for all types of polymers intended for food contact.

The Environmental Review Team has determined that allowing this notification to become effective will not significantly affect the quality of the human environment and therefore will not require the preparation of an environmental impact statement. This finding is based on an environmental assessment prepared by a scientist on the Environmental Review Team.

Prepared by: ____________________________________________ Date: March 15, 2000
John L. Dennison, Chemist
Environmental Review Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by: ___________________________________________ Date: March 15, 2000
Buzz Hoffmann, Ph.D., Team Leader
Environmental Review Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration

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